Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GPS Advanced; 5 cc GPS Advanced Cannula

K-Number: K241426 · 2024-07-10

ApplicantProsidyan, Inc.
Decision Date2024-07-10
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GPS Advanced; 5 cc GPS Advanced Cannula is the device name listed in this FDA 510(k) record. The listed applicant is Prosidyan, Inc.. It received FDA 510(k) clearance on 2024-07-10 under 510(k) number K241426. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GPS Advanced; 5 cc GPS Advanced Cannula?

GPS Advanced; 5 cc GPS Advanced Cannula is a medical device that received FDA 510(k) clearance on 2024-07-10. The listed applicant is Prosidyan, Inc.. The 510(k) number is K241426.

When did GPS Advanced; 5 cc GPS Advanced Cannula receive FDA 510(k) clearance?

GPS Advanced; 5 cc GPS Advanced Cannula received FDA 510(k) clearance on 2024-07-10, under 510(k) number K241426.

Who is the listed applicant for GPS Advanced; 5 cc GPS Advanced Cannula?

The FDA 510(k) record lists Prosidyan, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GPS Advanced; 5 cc GPS Advanced Cannula?

The FDA product code for GPS Advanced; 5 cc GPS Advanced Cannula is FMF.

Other records listing Prosidyan, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix Bone Graft Substitute FIBERGRAFT™ BG Matrix Bone Graft SubstituteK251648GPS Advanced; GPS Advanced CannulaK213803FIBERGRAFT Aeridyan Matrix Bone Graft SubstituteK182670FIBERGRAFT AERIDYAN Matrix Bone Graft SubstituteK180080FIBERGRAFT BG Matrix Bone Graft SubstituteK171284FIBERGRAFT BG Matrix Bone Graft Substitute

View all 8 devices →

Related Devices (Code: FMF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)Hlb Lifescience Co., Ltd.K252279Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)Chirana T.Injecta,A.S.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑